Business Imperatives

  • The client was seeking a Regulatory partner to assist with labeling-related activities in different regions, including the US, UK, Canada, Australia, and the EU.
  • The client approached Freyr for assistance in proofreading all labeling documents, such as the Core Data Sheet (CDS), local regional labeling documents (Summary of Product Characteristics (SmPC), United States Prescribing Information (USPI), Australian Prescribing Information (AUPI), Product Monograph (PM), etc.), and other labeling Regulatory documents.

Objectives

To provide meticulous formatting and comprehensive text review support of various multiple innovative medicines for serious diseases, ensuring alignment with Regulatory standards and enhancing readability across different regions.

Problem Statement

  • The quality of the final labeling documents with the client was not maintained in a standard format, necessitating massive formatting for all the documents for different regions in scope.
  • As there were different regions and multiple labeling documents involved, the client faced challenges with complying with the specific regional Regulatory requirements set by their respective Country’s Health Authorities.
  • With multiple regions being involved, there was also a language barrier that the client wanted help with.

Freyr Solutions and Services

Freyr Solutions and Services
  • All documents were fully formatted and meticulously reviewed against the source documents.
  • Comprehensive support was provided throughout the entire labeling process.
  • Freyr began by proofreading all the labeling documents that the client wanted to have proofread.
  • The proofreading activity was broken down into two activities:
    • Formatting: The formatting for all the documents.
    • Text Review: All the documents were compared with the source documents, and changes were made wherever required.
  • Freyr used internal checklists developed for different regions and shared them with the client along with the final proofread documents.
  • Achieved a TAT of around 10 hours per document.
  • A 100% right-first-time accuracy was achieved.
  • High-quality, submission-ready documents were delivered.
  • The streamlined proofreading process led to the rapid and accurate completion of documents on the first review. This ensured that high-quality, submission-ready documents were delivered quickly, enhancing efficiency and meeting client expectations.